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Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006231
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if radiation therapy is effective in preventing metastatic cancer following surgery.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing metastatic cancer in patients who have undergone diagnostic procedures to identify malignant mesothelioma.

Condition or disease Intervention/treatment Phase
Malignant Mesothelioma Perioperative/Postoperative Complications Procedure: quality-of-life assessment Procedure: standard follow-up care Radiation: radiation therapy Phase 3

Detailed Description:


  • Determine the efficacy of radiotherapy in the prevention of metastatic skin nodules or tumor seeding following invasive diagnostic procedures, such as chest drain insertion, pleural aspiration, pleural biopsy, and thoracoscopy, in patients with malignant mesothelioma.
  • Determine whether the nodules that develop after radiotherapy are symptomatic in these patients.
  • Compare the quality of life of patients treated with radiotherapy vs standard care alone.

OUTLINE: This is a randomized study.

Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive radiotherapy on 3 consecutive days beginning within 3 weeks after chest drain insertion, pleural aspiration, pleural biopsy, or thoracoscopy and once the wounds have healed.
  • Arm II: Patients receive standard supportive care alone. Quality of life is assessed at baseline, and then at 1, 2, 4, 6, 9, and 12 months.

Patients are followed at 1, 2, 4, 6, 9, and 12 months.

PROJECTED ACCRUAL: A total of 44 patients (22 per arm) will be accrued for this study within 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Primary Purpose: Treatment
Official Title: A Randomized Study to Assess Whether Radiotherapy Prevents Skin Lumps at Sites Where Needles or Tubes Have Been Inserted in Patients With Malignant Mesothelioma
Study Start Date : February 1998
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Primary Outcome Measures :
  1. Incidence of metastatic skin nodules

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven malignant pleural mesothelioma by chest drain insertion, pleural aspiration, pleural biopsy, and/or thoracoscopy within the past 3 weeks



  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • At least 3 months


  • Not specified


  • Not specified


  • Not specified


Biologic therapy:

  • Not specified


  • No prior systemic chemotherapy for malignant mesothelioma

Endocrine therapy:

  • Not specified


  • No prior local radiotherapy for malignant mesothelioma


  • See Disease Characteristics
  • No other invasive procedures to the same chest site during and for 1 year after study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006231

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United Kingdom
West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Gartnavel General Hospitall
Glasgow, Scotland, United Kingdom, G12 0YN
Stobhill General Hospital
Glasgow, Scotland, United Kingdom, G21 3UW
Sponsors and Collaborators
University of Glasgow
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Study Chair: Noelle O'Rourke, MD University of Glasgow
Publications of Results:
O'Rourke N, Paul J, Hill J: Radiotherapy to mesothelioma drain sites may not be worthwhile: interim report of a randomized study. Lung Cancer 29(1 Suppl 1): A-568, 168, 2000.

Layout table for additonal information Identifier: NCT00006231    
Other Study ID Numbers: CDR0000068155
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: October 2000
Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma
advanced malignant mesothelioma
perioperative/postoperative complications
Additional relevant MeSH terms:
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Lung Neoplasms
Postoperative Complications
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes